General

Synthetic biologists use artificial molecules to reproduce behaviour from natural biology. They aim to create artificial life or seek interchangeable biological parts to assemble into devices and systems that function in a unique way. Certain aspects in synthetic biology, in particular the deliberate synthesis of complex biological systems, have the capacity to change our approach to many key technologies and biotechnological applications. (1) The development of synthetic biology has several consequences. It has potential benefits such as the cheap production of drugs or chemicals. Although most people will agree synthetic biology is a good thing, one must not forget that there’s a back side. It’s important to consider the dangers of synthetic life forms. Ethics are playing an important role in international conferences indicating a need for ethical debate, regulation and safe practice. (2)

A code of ethics and standards should emerge for biological engineering as it has done for other engineering disciplines. - Church G. (3)

Learning from gene therapy, we should imagine worst-case scenarios and protect against them. - Church G. (3)

In literature five areas of concern on ethical biology can be identified: uncontrolled release in the environment, bioterrorism, patenting and the creation of monopolies, trade and global justice and the creation of artificial life. (4)

A major issue is the uncontrolled release of the biological machines, although most times a synthetic machine is too weak to survive in the wild. Therefore, an accidental release probably won't have major consequences. However,it’s important to consider the possibility. The threat of escape can be minimized by engineering bacteria dependent on nutrients that don’t occur in a natural environment. This will reduce there capacity to compete with endogenous species. Another solution is the use of synthetic components of DNA in such way that the organisms cannot replicate without them. Using a ‘self-destruct’ mechanism which is triggered when the population density becomes too large can be another way to minimize the risk. But biological machines are still evolutionary machines and are subject to natural selection and gene flow. Mutations in the genome of the synthetic organisms can interact with organisms living in the environment. This can result in unexpected and potentially dangerous new organisms. It may provide advantages over natural organisms leading to unexpected proliferation and changing the ecosystem. (4)

Synthetic biologists make major efforts to develop a toolbox that can bypass a massive research and technology process. As DNA sequencing becomes cheaper and it becomes easier to buy second hand equipment over the internet, more people are able to build their own biological machines. In this way synthetic biology might finally unleash the full potential of biotechnology and spark a wave of innovation, as more and more people have the necessary skills to engineer biology. (1) On the other hand, this can result in an uncontrolled use of synthetic biology. Already on the internet a publication on synthetic biology written in simple, non-technical language has appeared. (5) This allows everybody who’s able to get the right equipment to experiment with genes and organisms, including people who know nothing about the possible threat of synthetic organisms. Without certain restrictions, scenario's that could put the community and the environment under unprecedented risk are no longer just good movie material. The biohacker community acknowledged this subject by releasing a code of ethics stating: ‘be safe, do not damage anything, do not damage anyone, either physically, mentally or emotionally, be funny, at least to most of the people who experience it’. Saying this won't remove all potentially dangerous texts or malware programmes from the internet, but it shows an interest in safety issues.(1) Although the concept of biohacking is starting to develop over the internet, there isn’t much evidence that there’s any active practice. The creation of new dangerous and efficient species (deliberately or by accident) isn’t readily to occur. It’s more likely that there will be a threat from the creation of already known pathogens than from new synthetic organisms. Knowing the sequences of extremely deadly pathogens could pose threats to public safety and health that might outweigh the benefits. But even if these dangerous organisms can be produced, it’s hard to ‘weaponise’ them. (4)

Building new organisms raises commercialization issues that will affect the conduct of research and ability of industry and academia to continue development. The Chakrabarty case ruled that genetically altered organisms are not products of nature and thus are patentable. (7) Intellectual property management holds two concerns, namely patents that are too broad and those too narrow. Broad patents may restrict further development and narrow ones may over-complicate everything. The latter means that too many patents have to be negotiated which complicates the research process. (4) Current patenting practice may already be restricting development and access to clinical applications and researchers’ access to genetic information and reagents. A new regulatory framework need to ensure that public and commercial interests are protected.(7)